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Z-3090-2026 Class I Ongoing

Recalled by Given Imaging Ltd. — Yokne'Am Ilit

FDA device recall Z-3090-2026 was initiated by Given Imaging Ltd. on August 6, 2026 and is designated Class I. Reason for recall: Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/… The recall status is ongoing. Affected quantity: 127,416.

Recall Details

Product Type: Devices
Report Date: September 16, 2026
Initiation Date: August 6, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 127,416

Product Description

Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.

Reason for Recall

Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.

Distribution Pattern

Worldwide distribution. US nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Czech Republic, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Luxembourg, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, and United Kingdom.

Code Information

Product Number FGS-0635 UDI-DI (GTIN) 07290101369707 Product Number FGS-0636 UDI-DI (GTIN) 07290101369714 Expiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F)